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Clinical Trial Summary

we conducted a longitudinal 4-year clinical trial to determine the long-term effects of soy consumption on lipid profiles, renal-function indices and CRP level among type 2 diabetic patients with nephropathy.


Clinical Trial Description

Background: Several short-term trials on the effect of soy consumption on cardiovascular risks are available, but little evidence exists regarding the impact of long-term soy protein consumption among type 2 diabetic patients with nephropathy.

Objectives: To determine the effects of long-term soy consumption on cardiovascular risks, C-reactive protein and kidney-function indices among type 2 diabetic patients with nephropathy.

Design: This longitudinal randomized clinical trial was conducted among 41 type 2 diabetic patients with nephropathy (18 men and 23 women). Twenty patients in soy protein group consumed a diet containing 0.8 g protein/kg body weight (35% animal proteins, 35% textured soy protein, and 30% vegetable proteins) and 21 patients in control group consumed a similar diet containing 70% animal proteins and 30% vegetable proteins for 4-years. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00555490
Study type Interventional
Source Isfahan University of Medical Sciences
Contact
Status Completed
Phase Phase 1
Start date April 2001
Completion date September 2005

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